Can cerebral oximetry improve the treatment of head injury?
- Conditions
- Health Condition 1: S098- Other specified injuries of head
- Registration Number
- CTRI/2020/10/028511
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
We will include non-operatively managed, adult, TBI patients who present within 24 hours of trauma, and in whom the treating team anticipates a progression of CT findings or clinical deterioration in the next three days. This could be based on any combination of findings such as sizable contusions, acute subdural hematoma, and brain edema with partial or complete obliteration of cisterns. The decision will be made by the treating team. Since there are innumerable clinical situations, and due to the absence of level 1 (RCT) evidence for surgical decision making, we are not providing strict, exhaustive criteria, but we would like to leave it to the treating teamâ??s best judgment.
Patients who require immediate operative intervention as per judgment of the treatment team which is expected to follow the guidelines of the Brain Trauma Foundation. (The guidelines of the BTF for surgical intervention are not level 1 but are expert opinions themselves)
Patients who are planned for barbiturate coma or similar burst suppression techniques.
Pure diffuse axonal injury without edema or significant hematoma or cisternal obliteration where deterioration is only expected because of progressive axonal damage.
Pure brainstem contusions or pure posterior fossa hematomas.
A patient with traumatic great vessel dissection causing an infarct that is visible in the initial scan.
Patients who have multiple system injuries besides TBI, who could go into hypotension or hypoxia that could affect the rSO2 levels or who are already in hypotension or hypoxia due to any cause.
Patients who have large skin abrasion or laceration or contusion over the forehead, that prevents the application of the sensor electrodes
A patient with an extradural hematoma or a thick subdural hematoma (1 cm or more) or thick pneumocephalus (5 mm or more, confluent) overlying the frontal brain at the forehead area since the signal might be absorbed by the blood or air.
A patient with grossly depressed fracture at the forehead area
Patients who are in a poor neurological status that survival for a period of one week is deemed unlikely
A patient with previous cranioplasty or surgical evacuation of a hematoma that caused a porencephalic change in the frontal lobes that could interfere with measurements.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the diagnostic value of a drop in rSO2 (cerebral oximetry) in estimating the proportion of patients who have a radiological or clinical deterioration. <br/ ><br>Timepoint: Three days (72) hours from the time of application of the diagnostic device <br/ ><br>
- Secondary Outcome Measures
Name Time Method